BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine.
In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.

FDA DeterminedCause 2

PRODUCTION CONTROLS: Error in Labeling

Action

Spacelabs has sent the Urgent -Medical Device Correction-Spacelabs Healthcare BleaseFocus Anesthesia Workstation Blease 700/900 Series Ventilators letter, dated 16 November 2012, to US customers.
On November 26, 2012, a customer letter (translated as necessary) was
emailed to all international subsidiaries and distributors of record.
Customers are advised that the primary alarm will sound only in the event of an O2 supply failure and they will be provided with the corrected user and service manuals that do not reference a secondary O2 supply failure alarm.
Customers with questions can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.